NCT04487886

Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)

Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and will be identified and recruited by their treating physician and research team.

Detailed description

This randomized placebo-controlled phase 2 study will evaluate whether a two-week exposure to duvelisib, a gamma/delta phosphoinositide 3-kinase (PI3K) inhibitor, reduces inflammation in the lungs in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 who do not require mechanical ventilation at study initiation. The primary objective of the study is to determine the efficacy of duvelisib treatment in preventing death or the need for mechanical ventilation among patients with World Health Organization (WHO)-defined severe COVID-19. Key secondary endpoints will be reductions in oxygen requirements of patients and improvements in their performance status, safety and tolerability of duvelisib in the setting of COVID-19, biomarkers of inflammation, and generation of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody responses to SARS-Cov-2 spike protein. The study will determine if a two-week exposure to duvelisib beginning soon after presentation with severe COVID-19 warrants further evaluation in a larger clinical study.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Duvelisib	Duvelisib will be taken orally at an initial dose of 25 milligrams (mg) twice per day for 14 days. The dose will be de-escalated to 15 mg, twice per day, under certain clinical circumstances.
DRUG	Placebo	A placebo to match duvelisib will be taken orally twice per day for 14 days.

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-06-10
• Completion: 2021-06-10
• First posted: 2020-07-27
• Last updated: 2023-04-07
• Results posted: 2023-04-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study